03632307

GUDID H981036323070

TROCAR FOR NAVIGABLE CANNULATED AWL/PROBES/TAPS

Synthes GmbH

Orthopaedic trocar blade, reusable

• Primary Device ID: H981036323070
• NIH Device Record Key: 44a8ff80-8c07-42e2-b1e7-55f661ac3f1a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 03.632.307
• Catalog Number: 03632307
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034719733 [Primary]
HIBCC	H981036323070 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122211

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[H981036323070]

Moist Heat or Steam Sterilization

[H981036323070]

Moist Heat or Steam Sterilization

[H981036323070]

Moist Heat or Steam Sterilization

[H981036323070]

Moist Heat or Steam Sterilization

[H981036323070]

Moist Heat or Steam Sterilization

[H981036323070]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-01
• Device Publish Date: 2016-06-30

Devices Manufactured by Synthes GmbH

• 07612334270139 - EXPert Nail: 2025-10-02 TRAY F/TIBIAL NAIL EX SP INSTR
• H679310930 - NA: 2025-10-01 SMALL CHUCK WITH KEY
• 10886982350190 - NA: 2025-09-22 2.0MM STRAIGHT PLATE 20 HOLES
• 10887587078465 - NA: 2025-09-19 NONRETAINING SCREWDRIVER BLADE FOR 90DEG SCREWDRIVER
• 10886982349873 - NA: 2025-09-01 CANNULATED CIRCULAR REAMER 16MM
• 10886982349880 - NA: 2025-09-01 CANNULATED CIRCULAR REAMER 18MM
• 10886982349897 - NA: 2025-09-01 CANNULATED CIRCULAR REAMER 20MM
• 10886982349903 - NA: 2025-09-01 CANNULATED CIRCULAR REAMER 22MM